The Federal Court of Appeal (FCA) has held that in order to determine whether a patent claims an unpatentable method of medical treatment (MMT), it is necessary to determine whether the use of the invention requires
February 2024
Health Canada disclosing more information on pending generic drug submissions
On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will…
Drug pricing: PMPRB releases “What We Learned” Report on guidelines consultation
The Patented Medicine Prices Review Board (PMPRB or Board) has released a “What We Learned” Report (the Report), marking the next step along the path to new Guidelines. The Report was prepared by Phoenix Strategic Perspectives Inc.…
Federal Court finds trademark confusion between the names of two approved biologics
The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application…
Dormant drug status can trigger generic access to an alternate Canadian Reference Product
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is…
Federal Court of Appeal clarifies scope of implied licence on sale of patented medicine
The Federal Court of Appeal (FCA) has held that the sale of a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is…